As you and other public health advocates work on the front lines of the COVID-19 pandemic, we want you to know that we recognize your concerns about protecting the safety of yourselves, your families, and others you care for. The FDA's work is critical to ensuring the health and safety of the American public at any time, but is magnified during public health emergencies.
As we address the challenges of the COVID-19 pandemic, protecting the public's health, using science to guide our decisions, and facilitating access to critical medical products continue to be top priorities for the FDA.
It can be a difficult disease to diagnose and a difficult disease to treat. It's called lupus, and as many as 24,000 people in the United States are diagnosed with the disease each year. Scientists today are working on many fronts to understand the genetic underpinnings of the disease and to develop new and more targeted therapies to treat it.
FDA's National Center for Toxicological Research Celebrates Half a Century of Cutting-Edge Research
By: William Slikker, Jr., Ph.D., National Center for Toxicological Research Director and RADM Denise Hinton, Chief Scientist
The U.S. Food and Drug Administration is responsible for regulating products Americans use every day. From your toothbrush and moisturizer to your morning coffee, and the food you buy your pet, to your annual flu shot, the FDA regulates or oversees them all. To ensure the safety of these products, which account for about 20 cents of every dollar spent by U.S. consumers, the FDA's decisions must be based on sound regulatory science.
Vaccines Protect Children From Harmful Infectious Diseases
Vaccines are essential to getting children off to a healthy start in life.
Because immunization programs of the 20th and 21st century have been so successful, many parents today have never seen the many vaccine-preventable diseases that were once common. They don't realize that those infectious diseases could reemerge. If individuals choose not to vaccinate themselves or their children, some diseases that are now rare or nonexistent in the United States may resurface.
Proteins used as therapeutics have become an essential part of modern medicine. Immunogenicity (anti-drug antibodies that target the protein-therapeutic) is a significant impediment to development and licensure of any therapeutic-protein. The lecture will illustrate how judicious application of tools available for immunogenicity risk-assessment can permit better decision-making during drug-development, licensure, and clinical-trials.
The virtual conference will bring together outsourcing facilities, regulators and industry leadership to engage on emerging industry topics and best practices to improve the overall quality of compounded drugs, focusing on a culture of quality.
An optional pre-conference session geared toward first time attendees will be held on September 13, 2021.
September 14 - 15, 2021
Day 1: - ET Day 2: - ET
Registration is tentative until approved. Conference registration is free and includes access to an interactive platform as well as live sessions and presentations. Early registration is recommended.
The FDA Oncology Center of Excellence presents Conversations on Cancer - The Future of Childhood Cancer Drug Development: Is the Sky the Limit? Join this 1 ½ hour informal panel discussion exploring personal perspectives from survivors, clinicians, caregivers, and pediatric patient advocates on the impact of childhood cancer.
The FDA is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027.
During this meeting, the Patient Engagement Advisory Committee (the Committee) will discuss factors the FDA and industry should consider to effectively communicate medical device recall information to patients and the public, including but not limited to content, format, methods used to disseminate the message, and timing of communication. The Committee will consider concerns patients have about changes to their device in response to a recall and ways patient perspectives could be incorporated in the FDA's and industry's benefit-risk decision-making of recalled medical devices.
October 6, 2021; 10:00 AM - 5:00 PM ET
Registration is not required.
About Us
The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.
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